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    Clinical Trial Results:
    Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients with Seasonal Allergic Rhinitis

    Summary
    EudraCT number
    		 2011-001369-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Jun 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MP4002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00651118
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Meda Pharmaceuticals Inc.
    Sponsor organisation address
    265 Davidson Avenue, Suite 300, Somerset, United States, NJ 08873-4120
    Public contact
    Group leader study manager, MEDA Pharma GmbH & Co. KG, +49 617288801, 42b@medapharma.de
    Scientific contact
    Head Corporate Clinical Affairs, MEDA Pharma GmbH & Co. KG, +49 617288801, 42b@medapharma.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000990-PIP02-10
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare efficacy and safety of azelastine hydrochloride and fluticasone propionate combination nasal spray to placebo and to each product alone.
    Protection of trial subjects
    No specific additional measures to minimise pain and distress were required. The patients could withdraw from treatment at any time and for any reason.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Mar 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 832
    Worldwide total number of subjects
    832
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    98
    Adults (18-64 years)
    706
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study began with a 7-day single-blind Placebo Lead-in Period during which subjects recorded symptom scores twice daily in order to qualify for randomization to the double-blind treatment period. On Visit 2 subjects who satisfied the symptom requirements and continued to meet all of the study inclusion/exclusion criteria were randomized.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MP29-02
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azelastine hydrochloride and fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Total Daily Dose: 548 mcg azelastine/200 mcg fluticasone; 1 spray per nostril twice daily; 2-week study

    Arm title
    		 Azelastine HCL
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azelastine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray per nostril twice daily; total daily dose: 548 mcg azelastine; 2-week study

    Arm title
    		 Fluticasone
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluticasone propionate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray per nostril twice daily; total daily dose: 200 mcg fluticasone; 2-week study

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Same formulation as MP29-02 used with the exception of the active ingredients; 1 spray per nostril twice daily; 2-week study

    Number of subjects in period 1
    		MP29-02 Azelastine HCL Fluticasone Placebo
    Started
    207
    208
    207
    210
    Completed
    198
    197
    200
    203
    Not completed
    9
    11
    7
    7
         Consent withdrawn by subject
    -
    1
    1
    1
         Adverse event, non-fatal
    4
    1
    -
    1
         Other
    1
    2
    4
    1
         Lost to follow-up
    2
    1
    -
    2
         Protocol deviation
    2
    6
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MP29-02
    Reporting group description
    		 -

    Reporting group title
    Azelastine HCL
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 MP29-02 Azelastine HCL Fluticasone Placebo Total
    Number of subjects
    		 207 208 207 210 832
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 19 28 15 36 98
        Adults (18-64 years)
    		 183 172 185 165 705
        65 or older
    		 5 8 7 8 28
        not reported / not in ITT
    		 0 0 0 1 1
    Gender categorical
    Units: Subjects
        Female
    		 142 130 127 132 531
        Male
    		 65 78 80 77 300
        not reported / not in ITT
    		 0 0 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    MP29-02
    Reporting group description
    		 -

    Reporting group title
    Azelastine HCL
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Change From Baseline in 12-Hour Reflective Total Nasal Symptom Score over the 14-Day Treatment Period: AM and PM Combined

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    End point title
    		 Change From Baseline in 12-Hour Reflective Total Nasal Symptom Score over the 14-Day Treatment Period: AM and PM Combined
    End point description
    End point type
    Primary
    End point timeframe
    Day 1 PM to day 14 AM
    End point values
    		 MP29-02 Azelastine HCL Fluticasone Placebo
    Number of subjects analysed
    207
    208
    207
    209 [1]
    Units: difference in scores
        least squares mean (standard deviation)
    -5.61 ± 5.235
    -4.23 ± 4.629
    -4.71 ± 4.678
    -2.92 ± 3.923
    Notes
    [1] - One randomized subject not in the ITT population.
    Statistical analysis title
    		 Comparison MP29-02 vs Placebo
    Comparison groups
    MP29-02 v Placebo
    Number of subjects included in analysis
    416
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001 [2]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [2] - Pre-specified with multiplicity adjustement (gatekeeping).
    Statistical analysis title
    		 Comparison MP29-02 vs Azelastine
    Comparison groups
    MP29-02 v Azelastine HCL
    Number of subjects included in analysis
    415
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001 [3]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [3] - Pre-specified with multiplicity adjustement (gatekeeping).
    Statistical analysis title
    		 Comparison MP29-02 vs Fluticasone
    Comparison groups
    MP29-02 v Fluticasone
    Number of subjects included in analysis
    414
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.034 [4]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [4] - Pre-specified with multiplicity adjustement (gatekeeping).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    MP29-02
    Reporting group description
    		 548 mcg azelastine/200 mcg fluticasone

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Fluticasone
    Reporting group description
    		 200 mcg

    Reporting group title
    Azelastine HCL
    Reporting group description
    		 548 mcg

    Serious adverse events
    		 MP29-02 Placebo Fluticasone Azelastine HCL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 207 (0.00%)
    0 / 210 (0.00%)
    0 / 207 (0.00%)
    0 / 208 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 MP29-02 Placebo Fluticasone Azelastine HCL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 207 (14.49%)
    24 / 210 (11.43%)
    32 / 207 (15.46%)
    26 / 208 (12.50%)
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    5 / 207 (2.42%)
    1 / 210 (0.48%)
    2 / 207 (0.97%)
    7 / 208 (3.37%)
         occurrences all number
    5
    1
    2
    7
    Headache
         subjects affected / exposed
    2 / 207 (0.97%)
    4 / 210 (1.90%)
    7 / 207 (3.38%)
    2 / 208 (0.96%)
         occurrences all number
    2
    4
    7
    2
    General disorders and administration site conditions
    Mucosal erosion
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    2 / 207 (0.97%)
    0 / 208 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 207 (0.48%)
    0 / 210 (0.00%)
    2 / 207 (0.97%)
    1 / 208 (0.48%)
         occurrences all number
    1
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal discomfort
         subjects affected / exposed
    2 / 207 (0.97%)
    0 / 210 (0.00%)
    2 / 207 (0.97%)
    4 / 208 (1.92%)
         occurrences all number
    2
    0
    2
    4
    Epistaxis
         subjects affected / exposed
    3 / 207 (1.45%)
    2 / 210 (0.95%)
    5 / 207 (2.42%)
    4 / 208 (1.92%)
         occurrences all number
    3
    2
    5
    4
    Sneezing
         subjects affected / exposed
    1 / 207 (0.48%)
    1 / 210 (0.48%)
    0 / 207 (0.00%)
    2 / 208 (0.96%)
         occurrences all number
    1
    1
    0
    2
    Cough
         subjects affected / exposed
    2 / 207 (0.97%)
    0 / 210 (0.00%)
    0 / 207 (0.00%)
    1 / 208 (0.48%)
         occurrences all number
    2
    0
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 207 (1.93%)
    1 / 210 (0.48%)
    1 / 207 (0.48%)
    1 / 208 (0.48%)
         occurrences all number
    4
    1
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2008
    Amendment included changes to some eligibility critiera and some administrative modifications
    11 Mar 2008
    Amendment included changes to the methodology, sample size, more specific details on procedures, and some administrative modifications.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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